Phase 3
N=48
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis
Eosinophilic Gastroenteritis
Bottom Line
View on ClinicalTrials.gov: NCT05214768 ↗Enrolled (actual)
48
Serious AEs
1.1%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies — -100.4; 122.8 Peak # of eosinophils counted per field — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CC-93538 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies |
-100.4; 122.8 | 0.003 sig |
| SECONDARY Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16 |
-1.9; -1.7; -2.1; -0.9; -2.1; -2.2 | — |
| SECONDARY Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48 |
0.2; -2.0; -1.4; 0.1; -2.5; -1.8 | — |
| SECONDARY Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16 |
6.3; 0 | — |
| SECONDARY Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48 |
0; 8.3; 0 | — |
| SECONDARY Induction + Maintenance: Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies at Week 48 |
-24.1; -151.2; 98.6 | — |
| SECONDARY Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline |
-13.4; 61.6 | — |
| SECONDARY Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline |
7.2; -39.9; 43.7 | — |
| SECONDARY Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) |
15.6; 0 | — |
| SECONDARY Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction) |
0; 25.0; 0 | — |
| SECONDARY Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale |
28.1; 18.8 | — |
| SECONDARY Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale |
10.0; 25.0; 31.3 | — |
| SECONDARY Induction Phase: Changes in Total Score of Eosinophilic Gastrointestinal Disorder (EGID) Severity Score From Baseline to Weeks 16 in Adolescent (12 to 19 Years) |
-6.4; -3.8 | — |
| SECONDARY Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years) |
-5.5; -4.5 | — |
| SECONDARY Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years) |
7.1; -10.4; 1.7 | — |
| SECONDARY Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years) |
-3.3; -2.4; -7.2 | — |
| SECONDARY Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy |
NA; NA; NA; NA | — |
| SECONDARY Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use |
NA; NA; NA | — |
| SECONDARY Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events |
16; 9; 13; 0; 1; 0 | — |
| SECONDARY Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements |
0; 0; 0 | — |
| SECONDARY Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters |
0; 0; 0 | — |
| SECONDARY Induction and Maintenance: Number of Participants With Mean Changes Over Time That Were of Clinically Concern in Hematology Parameters, Serum Chemistry Parameters, and Urinalysis Parameters |
0; 0; 0 | — |
| SECONDARY Induction and Maintenance: Number of Participants With Anti-Drug-Antibody |
2; 0 | — |
| SECONDARY Induction Phase: CC-93538 Trough Concentration at Week 16 |
179472.2 | — |
| SECONDARY Maintenance Phase: CC-93538 Trough Concentration at Week 48 |
165591.7; 76433.4 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.
Eligibility Criteria
Inclusion Criteria
- Histologic evidence of eosinophilic gastroenteritis (EGE) defined as ≥ 30 eosinophils (eos)/high-power field (hpf) in at least 5 hpf in the stomach and/or ≥ 30 eos/hpf in at least 3 hpf in the duodenum while on stable background therapy for EGE
- Has weekly symptom scores of ≥ 4/15 for any of Gastric Pain Symptoms domain, Stomach Heaviness Symptom domains, and /or Diarrhea Symptoms domain as assessed by the Izumo Scale with electronic device for the 2 consecutive weeks before Day 1
- Must agree to maintain a stable diet from the first Screening Visit and throughout the duration of the study, and participants must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit
- Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose
Exclusion Criteria
- Ascites requiring treatment or symptomatic ascites
- History of inflammatory bowel disease, achalasia or esophageal surgery
- Has other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA)
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT05214768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.